Obetohep 10 Mg Tablet (10 Tab)

OBETOHEP 10 MG TABLET

OBETOHEP 10 MG TABLET is a medication manufactured by ALKEM LABORATORIES LTD., primarily used in the management of chronic liver conditions.

• Name:

  • Brand Name: OBETOHEP 10 MG TABLET
  • Common Name: Obeticholic acid

• Composition: Each tablet contains 10 mg of Obeticholic acid.

• Uses: OBETOHEP 10 MG TABLET is prescribed for the treatment of primary biliary cholangitis (PBC), also known as primary biliary cirrhosis. It can be used alone or in combination with Ursodeoxycholic acid (UDCA) in patients who do not respond adequately to UDCA, or as a monotherapy for those unable to tolerate UDCA. Obeticholic acid works by activating the farnesoid X receptor (FXR), which helps regulate bile acid production and flow, reduces liver inflammation, and improves liver function.

• Dosage and Administration: This medicine should be taken exactly as prescribed by a doctor. Swallow the tablet whole with a glass of water; do not crush or chew it. It can be taken with or without food, but maintaining a consistent daily time is recommended for better results. Typically, it is taken once daily.

• Side Effects: Common side effects include:

  • Itching (pruritus)
  • Fatigue
  • Abdominal pain or discomfort
  • Dizziness
  • Constipation
  • Rash
  • Throat pain (oropharyngeal pain)
  • Joint pain
  • Eczema
  • Thyroid disorders
  • Peripheral edema
  • Palpitations
  • Fever If severe side effects occur or symptoms worsen, consult a doctor. Overdose symptoms can include yellowing of the skin or eyes, dark urine, loss of appetite, pain in the upper right abdomen, nausea, vomiting, and fluid accumulation in the abdomen.

• Precautions:

  • Pregnancy and Breastfeeding: Use with caution during pregnancy and breastfeeding; consult a doctor. It is not advisable for breastfeeding mothers as it may transfer through breast milk.
  • Alcohol: Avoid or limit alcohol consumption as it may worsen liver function.
  • Liver Conditions: Not recommended for patients with complete biliary obstruction or decompensated cirrhosis. Caution should be exercised in elderly patients and those with liver impairment; regular monitoring of liver function is essential.
  • Drug Interactions: Inform your doctor about all medications being taken as certain drugs can interact. Warfarin may require dose adjustment, theophylline can cause severe adverse effects, and tizanidine's effectiveness may increase.
  • Food Interactions: Avoid consuming grapefruit or grapefruit juice, as it may increase the risk of side effects.
  • Do not stop taking the medication without consulting your doctor. Not recommended for children or adolescents.

• Storage: Store OBETOHEP 10 MG TABLET in a cool and dry place, at room temperature (around 25°C). Protect it from light and moisture. Keep out of reach of children. Do not use after the expiry date.

What is OBETOHEP 10 MG TABLET used for?

OBETOHEP 10 MG TABLET is primarily used to treat primary biliary cholangitis (PBC), also known as primary biliary cirrhosis, in adults. It can be prescribed either alone or in combination with other therapies. This medication helps manage the chronic liver disease and can prevent or delay liver damage, especially when started in the early stages.

How does OBETOHEP 10 MG TABLET work?

The active ingredient in OBETOHEP 10 MG TABLET is Obeticholic acid (10 mg), which is a farnesoid X receptor (FXR) agonist. It works by activating FXR in the liver, which plays a crucial role in regulating the synthesis and transport of bile acids. This action helps reduce the accumulation of bile and inflammation in the liver, enhances bile flow, and ultimately protects liver cells from damage.

What is the usual dosage for OBETOHEP 10 MG TABLET?

The dosage of OBETOHEP 10 MG TABLET is determined by your doctor based on individual factors. Typically, treatment starts with 5 mg once a day for the first three months. Your doctor may adjust the dose as needed and tolerated, but it should not exceed 10 mg once daily. It is recommended to take the tablet at a fixed time each day, with or without food, and swallow it whole without crushing or breaking it.

What are the possible side effects of OBETOHEP 10 MG TABLET?

Common side effects associated with OBETOHEP 10 MG TABLET include constipation, dizziness, tiredness or fatigue, stomach pain or abdominal discomfort, itching (pruritus), rash, throat pain (oropharyngeal pain), joint pain, eczema, and thyroid disorders. Most side effects are temporary and resolve over time, but if they persist or worsen, you should consult your doctor.

Is OBETOHEP 10 MG TABLET safe during pregnancy or breastfeeding?

OBETOHEP 10 MG TABLET is generally not advisable during pregnancy as information regarding its use is limited. Similarly, it is not recommended for breastfeeding mothers as it may pass into breast milk. It is crucial to consult your doctor before taking this medication if you are pregnant, planning to become pregnant, or breastfeeding.

Can OBETOHEP 10 MG TABLET be taken with other medications?

OBETOHEP 10 MG TABLET can interact with certain medications. For instance, it may affect blood thinners like warfarin, medicines used for wheezing such as theophylline, and muscle relaxants like tizanidine. Co-administration with cyclosporine may also lead to clinical symptoms. It is very important to inform your doctor about all other medications, supplements, and herbal remedies you are currently taking to avoid potential interactions.

What precautions should be taken while using OBETOHEP 10 MG TABLET?

Several precautions should be observed. This medicine is not recommended for individuals with a complete blockage of the biliary tract, decompensated cirrhosis, a prior decompensation event, or compensated cirrhosis with evidence of portal hypertension. Alcohol consumption should be avoided or limited as it may worsen liver function. Your liver function will be closely monitored during treatment. Do not stop taking the medicine without consulting your doctor, even if symptoms improve. It is also advisable to avoid grapefruit or grapefruit juice. Use with caution in older patients, and it is not recommended for children or adolescents. As it may cause dizziness, exercise caution when driving or operating machinery.

What happens if a dose of OBETOHEP 10 MG TABLET is missed?

If you miss a dose of OBETOHEP 10 MG TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should OBETOHEP 10 MG TABLET be stored?

OBETOHEP 10 MG TABLET should be stored at room temperature, around 25°C. It should be protected from light and moisture and kept out of reach of children. Do not use the medicine after its expiry date.